Label: ALLERGY RELIEF- cetirizine hcl 10 mg capsule, liquid filled
- NDC Code(s): 69168-392-25
- Packager: Allegiant Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Updated December 31, 2018
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- Active ingredient (in each softgel)
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing hydroxyzine
Ask a doctor before use if you have
liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product
- drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and tranquilizers may increase drowsiness
- be careful when drivinga motor vehicle or operating machinery
Stop use and ask doctor
if an allergic reaction to this product occurs. Seek medical help right away.
- Keep Out of Reach of Children
- Adults and children 6 years and over: one 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms
- Adults 65 years and over: ask a doctor
- Children under 6 years of age: ask a doctor
- Consumers with liver or kidney disease: ask a doctor
- Other information
- Inactive Ingredients
- Questions or Comments?
- Package/Label Principal Display Panel
INGREDIENTS AND APPEARANCE
cetirizine hcl 10 mg capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-392 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg Inactive Ingredients Ingredient Name Strength BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) SODIUM HYDROXIDE (UNII: 55X04QC32I) Product Characteristics Color YELLOW Score no score Shape OVAL Size 14mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-392-25 1 in 1 CARTON 12/16/2014 1 25 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078317 12/16/2014 Labeler - Allegiant Health (079501930)